COPD (Chronic Obstructive Pulmonary Disease)NCT06717659
Probiotics in Pulmonaty Rehabilitation for COPD
A study testing probiotic supplementation intervention and standard pulmonnary rehabilitation in people with COPD (Chronic Obstructive Pulmonary Disease) and Probiotic Intervention, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
This study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. The focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Probiotic Intervention, Body Composition Measurement
- What is being tested?
- probiotic supplementation intervention and standard pulmonnary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign a written informed consent form.
- Diagnosed with pre-COPD or COPD stage I-IV according to the 2023 GOLD guidelines.
- Undergoing pulmonary rehabilitation therapy for more than three months.
Who cannot join
- Under 18 years old.
- Diagnosed with neuromuscular diseases.
- Experienced respiratory disease exacerbation requiring emergency care or hospitalization in the past three months.
- Unable to cooperate with cardiopulmonary exercise testing.
- Has other diseases or behavioral restrictions preventing participation in exercise training for over one year.
- Assessed by a physician to have severe malnutrition or a significantly low BMI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
Ke-Yun Chao, PhD, +886-905-301-879, C00152@mail.fjuh.fju.edu.tw
Ke-Yun Chao, PhD
About this study
Official title: Probiotics in the Management of Pulmonary Rehabilitation for COPD: A Randomized Controlled Trial
This study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. The focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition analyses, and biochemical blood parameters, with a primary emphasis on the anti-inflammatory response.
Read the detailed description
Background： Patients with chronic obstructive pulmonary disease (COPD) often suffer from malnutrition and weight loss, which negatively impact mortality rates. Research indicates that insufficient intake of fiber, vitamins, and folic acid is associated with airflow limitation in COPD. Malnutrition affects lung function and muscle strength, leading to difficulty in breathing and reduced exercise tolerance. Nutritional support interventions, such as probiotics, are valuable in improving the nutritional status, lung function, and pulmonary rehabilitation in COPD patients.
Study Design： This is a one-year, single-center, prospective randomized controlled trial.
Methods： This study is a randomized controlled trial targeting COPD patients undergoing pulmonary rehabilitation. The plan is to recruit 60 participants, randomly assigned to either the probiotic intervention group or the conventional pulmonary rehabilitation group. The study includes physiological parameters, functional tests, questionnaires, and blood biochemical analyses. Data will be analyzed using SPSS, with statistical significance set at p < 0.05.
Effect： The trial expects that COPD patients receiving probiotic supplementation will achieve significant muscle gain and fat loss, reduce inflammation, and exhibit changes in body composition and functional performance.
Key words： Chronic obstructive pulmonary disease; probiotics; nutritional supplementation; inflammation markers; body composition
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Probiotic Intervention, Body Composition Measurement
- Being tested
- probiotic supplementation intervention, standard pulmonnary rehabilitation
- Keywords
- body composition, inflammation markers, nutritional supplementation, probiotics, chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic supplementation interventionOther
probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy
standard pulmonnary rehabilitationOther
undergo routine pulmonary rehabilitation without probiotics intervention
| Study group | Role | What they receive |
|---|---|---|
| probiotic group | Experimental | receive probiotics alongside standard pulmonary rehabilitation therapy Receives: Other: probiotic supplementation intervention |
| pulmonary rehabilitation group | Active comparator | undergo only the standard pulmonary rehabilitation program Receives: Other: standard pulmonnary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin-6
inflammation evaluation
Measured: six weeks
Secondary outcomes (18)
indirect calorimetry
nutrition status
Measured: six weeks
body composition analysis
nutrition status
Measured: six weeks
heart rate
physiological parameters
Measured: six weeks
saturation
physiological parameters
Measured: six weeks
systolic and diastolic pressure
physiological parameters
Measured: six weeks
respiratory rate
physiological parameters
Measured: six weeks
six minute walk test
functional performance
Measured: six weeks
time up and go
functional performance
Measured: six weeks
FEV1
functional performance
Measured: six weeks
FVC
functional performance
Measured: six weeks
FEV1/FVC
functional performance
Measured: six weeks
CRP
biochemical blood tests
Measured: six weeks
TNF-α
biochemical blood tests
Measured: six weeks
TMAO
biochemical blood tests
Measured: six weeks
The MDA of oxidative stress
biochemical blood tests
Measured: six weeks
modified medical research council
self-perception questionnaire, maximun 4 and minimum 0, lower means a better outcome
Measured: six weeks
COPD assessment test
self-perception questionnaire, maximun 40 and minimum 0, lower means a better outcome
Measured: six weeks
Borg dyspnea scale
self-perception questionnaire, maximun 10 and minimum 0, lower means a better outcome
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start5 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717659
- Sponsor's protocol ID
- FJUH113385
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in the Management of Pulmonary Rehabilitation for COPD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06717659
- Acronym / sponsor ID
- FJUH113385
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Probiotic Intervention, Body Composition Measurement
- Keywords
- body composition, inflammation markers, nutritional supplementation, probiotics, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. The focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition analyses, and biochemical blood parameters, with a primary emphasis on the anti-inflammatory response.
Detailed description
Background： Patients with chronic obstructive pulmonary disease (COPD) often suffer from malnutrition and weight loss, which negatively impact mortality rates. Research indicates that insufficient intake of fiber, vitamins, and folic acid is associated with airflow limitation in COPD. Malnutrition affects lung function and muscle strength, leading to difficulty in breathing and reduced exercise tolerance. Nutritional support interventions, such as probiotics, are valuable in improving the nutritional status, lung function, and pulmonary rehabilitation in COPD patients.
Study Design： This is a one-year, single-center, prospective randomized controlled trial.
Methods： This study is a randomized controlled trial targeting COPD patients undergoing pulmonary rehabilitation. The plan is to recruit 60 participants, randomly assigned to either the probiotic intervention group or the conventional pulmonary rehabilitation group. The study includes physiological parameters, functional tests, questionnaires, and blood biochemical analyses. Data will be analyzed using SPSS, with statistical significance set at p < 0.05.
Effect： The trial expects that COPD patients receiving probiotic supplementation will achieve significant muscle gain and fat loss, reduce inflammation, and exhibit changes in body composition and functional performance.
Key words： Chronic obstructive pulmonary disease; probiotics; nutritional supplementation; inflammation markers; body composition
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic group | Experimental | Other: probiotic supplementation interventionreceive probiotics alongside standard pulmonary rehabilitation therapy |
| pulmonary rehabilitation group | Active comparator | Other: standard pulmonnary rehabilitationundergo only the standard pulmonary rehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to sign a written informed consent form.
- Diagnosed with pre-COPD or COPD stage I-IV according to the 2023 GOLD guidelines.
- Undergoing pulmonary rehabilitation therapy for more than three months.
Key exclusion criteria (6 listed)
- Under 18 years old.
- Diagnosed with neuromuscular diseases.
- Experienced respiratory disease exacerbation requiring emergency care or hospitalization in the past three months.
- Unable to cooperate with cardiopulmonary exercise testing.
- Has other diseases or behavioral restrictions preventing participation in exercise training for over one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic supplementation interventionprobiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy | Other | probiotic group |
| standard pulmonnary rehabilitationundergo routine pulmonary rehabilitation without probiotics intervention | Other | pulmonary rehabilitation group |
Primary outcome
interleukin-6
Time frame: six weeks
inflammation evaluation
18 secondary outcomes
indirect calorimetry
Time frame: six weeks
body composition analysis
Time frame: six weeks
heart rate
Time frame: six weeks
saturation
Time frame: six weeks
systolic and diastolic pressure
Time frame: six weeks
respiratory rate
Time frame: six weeks
six minute walk test
Time frame: six weeks
time up and go
Time frame: six weeks
FEV1
Time frame: six weeks
FVC
Time frame: six weeks
FEV1/FVC
Time frame: six weeks
CRP
Time frame: six weeks
TNF-α
Time frame: six weeks
TMAO
Time frame: six weeks
The MDA of oxidative stress
Time frame: six weeks
modified medical research council
Time frame: six weeks
COPD assessment test
Time frame: six weeks
Borg dyspnea scale
Time frame: six weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic supplementation intervention and standard pulmonnary rehabilitation in people with COPD (Chronic Obstructive Pulmonary Disease) and Probiotic Intervention, run by Fu Jen Catholic University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke-Yun Chao, PhD (+886-905-301-879, C00152@mail.fjuh.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interleukin-6 (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.